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Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01902303
First Posted: July 18, 2013
Last Update Posted: April 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Norwich Clinical Research Associates Ltd.
Hill Top Research
Information provided by (Responsible Party):
Beech Tree Labs, Inc.
  Purpose
The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.

Condition Intervention Phase
Oral Herpes Simplex Drug: Matching Placebo Drug: BTL-TML-HSV Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Cold Sore Treatments on UV Induced Cold Sores

Resource links provided by NLM:


Further study details as provided by Beech Tree Labs, Inc.:

Primary Outcome Measures:
  • Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator [ Time Frame: Day 0- Day 7 ]
    The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.


Secondary Outcome Measures:
  • Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant [ Time Frame: 0 -7 days ]
    The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.


Enrollment: 303
Study Start Date: July 2013
Study Completion Date: February 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Matching Placebo
Matching Placebo
Drug: Matching Placebo
Sublingual micro dosing of placebo for 7 days
Experimental: BTL-TML-HSV
Experimental Product
Drug: BTL-TML-HSV
Sublingual micro dosing of BTL-TML-HSV for 7 days

Detailed Description:

This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design

The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.

The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.

The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical history of recurrent cold sores averaging 2 or more episodes per year
  • UV exposure is known to cause a cold sore outbreak

Exclusion Criteria:

  • History of abnormal reactions to sunlight
  • Used antiviral therapy directly prior to entering study
  • Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902303


Locations
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33714
United States, Ohio
Hill Top Research
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Beech Tree Labs, Inc.
Norwich Clinical Research Associates Ltd.
Hill Top Research
Investigators
Study Director: John McMichael, PhD President, Beech Tree Labs, Inc.
  More Information

Responsible Party: Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier: NCT01902303     History of Changes
Other Study ID Numbers: BTL - 2013-06-0161
HTR - 13-131178 ( Other Identifier: Hill Top Research )
First Submitted: July 15, 2013
First Posted: July 18, 2013
Results First Submitted: February 14, 2016
Results First Posted: March 14, 2016
Last Update Posted: April 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Beech Tree Labs, Inc.:
Herpes Labialis
Herpes Simplex
Herpes
Ultra Violet (UV) Induced

Additional relevant MeSH terms:
Herpes Simplex
Herpes Labialis
Stomatitis, Herpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Stomatitis